The invention concerns processes and products for the indication of infection such as in vaginitis.
Vaginal infections are the most common women's health problem, and commonly or medically referred to as vaginitis. Vaginal infections are the most frequent reason American women see their doctors, and account for more than 10 million office visits per year. Vaginal infection (“vaginitis”), for example, exists in three primary forms, i.e., bacterial vaginosis, candidal vaginitis (“yeast”), and trichomonas vaginitis (“trich”). The most prevalent type of infection is bacterial vaginosis, affecting up to 40 to 50% of American women of childbearing age.
Evidence suggests that pregnant women diagnosed with bacterial vaginosis have an elevated risk for preterm labor or premature rupture of the amniotic membrane, putting both mother and baby at higher risk. Additional possible adverse outcomes include an increased frequency of abnormal papanicolaou (Pap) smears, pelvic inflammatory disease and endometritis.
The most characteristic symptoms of vaginal infection are discharge, odor, irritation, and elevation of pH and amine(s) level. Various mono- and di-amines are produced by anaerobic bacteria, and result in odor in the vaginal fluid with bacterial vaginosis.
Various techniques have been developed in an attempt to rapidly diagnose the forms of vaginitis. For example, microbiological techniques have been utilized to identify “clue cells” (vaginal epithelial cells with adherent surface bacteria). Conventional techniques for confirming the presence of “clue cells”, however, are often complicated and slow. Likewise, techniques have been utilized that detect an elevated pH level in an infected sample. Unfortunately, conventional techniques for detecting an elevated pH level are often misleading due to other factors, such as the use of antimicrobials and cervical discharge, which also cause an elevated pH. Several detection methods are known for amines, these methods, however, have complex multiple steps, require expensive instrumentation, or are time-consuming.
It is clear that there exists a need for a process and product which allows for the rapid, inexpensive, and non-invasive detection of vaginitis infections.